The Global Lean Transformation Program Transformation by the numbers 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

This presentation is based on publicly available information; DISCLAIMER This presentation is based on publicly available information; These slides are intended for educational purposes only and for the personal use of the audience. These slides are not intended for wider distribution outside the intended purpose without presenter approval; The content of this slide deck is accurate to the best of the presenter’s knowledge at the time of production.  The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of Roche or any of its officers. The views and opinions expressed in this presentation are those of the presenter. They do not reflect any strategic or business intent of their employer and they are not considered in any way a public communication of the presenter’s employer. The presenter’s employer does not endorse or support the views and opinions expressed within this presentation. 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Speaker background Professional Manager with over 20 years of experience as a change agent within manufacturing companies Key leader of Lean Six Sigma business transformation Expert knowledge in the following management tools: Strategic Planning/Policy Deployment, Lean Six Sigma Transformation, Dashboard Metrics, Kaizen, Project Management, Quality System Regulations, CAPA System, DMAIC, and Root Cause Analysis. Facilitated, coached or led over 250 operational excellence events during career. 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

agenda Global Lean Transformation Program Strategic Deployment Value Stream Management Building People Capabilities Governance of Lean Program 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Lean Transformational Model Draft of future state 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Global Lean Transformation- Checklist for Success 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Global Lean Transformation- How to start Change Management Selective Tools SME Development Training Organize for OPEX Provide Resources Kaizen Product / Value Immersion Program Theory Training Engagement Leadership T0 Time T +12 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

Strategic Deployment 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

Strategic Deployment Process Inputs to Filter: FDA VOC Sales Marketing Target Letters R&D Business Strategic Filter Catch Ball between GM, staff and ET Catch Ball between VS Leaders and GM/Staff Filtered Objectives Alignment between Site and Enterprise Alignment between VS and Site Enterprise Level- Executive Level SD Site Level- GM and Staff Level SD Value Stream Level- Middle and Front line Leaders SD 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Value Stream Management 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

“Value Stream Mapping” A Tool to help ID Waste in the Organization 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only Traditional Batch and Que Value Stream Map

Lean Transformation Roadmap Annual Plan 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

6 | Global Lean Transformation Model | Christian D 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Building People capabilities through rapid improvement improvements 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

Kaizen or Rapid Improvement Event Process 12 Week Cycle ID Event State Lean Tool expected improvement Plan event date and Record on Event Calendar Value Stream Mapping Event Pre Work- 7 weeks prior to Event. Establish team, Develop Charter, ID facilitator, train, And brainstorm. Hold weekly team Meetings, and gain approval. 7 weeks prior to event Event Week- Make Improvements, PDCA Event Week VSA, RIE, VVS, 6-Sigma (DMAIC), 3P (7 Alternatives), A3, TPOC, DOE, Known proven solutions, 6S, Load-Load, Standard Work, Policy Deployment, SMED, TPM, Inventory Reduction, Visual Workplace, Flow Map Sustainment- Team monitors, Adjusts, and sustains Improvement activities Cultural, Socio-Technical, and Economic Breakthroughs 4 weeks after event 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Kaizen or Rapid Improvement Event Process 12 Week Cycle VSA, RIE, VVS, 6-Sigma (DMAIC), 3P (7 Alternatives), A3, TPOC, DOE, Known proven solutions, 6S, Load-Load, Standard Work, Policy Deployment, SMED, TPM, Inventory Reduction, Visual Workplace, Flow Map

Rate of development Number of people in the organization assigned as SME’s 3% of workforce assigned to OPEX Number of RIE at each location, globally 1 RIE per month for every 100 employees 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Governance 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

Standard Work Communication Tools Area of Flow populates its performance hourly Front Line Leaders populate data daily on the SQDC Communication board Site Leaders populate the Dashboard monthly. 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only VS Leaders populate data on the VS Board weekly

Leader Standard Work - Senior Leader Immersion Plan 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Leader Standard Work - Leader standard work 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

The Model to Lean Transformation Enterprise Strategy The Model to Lean Transformation Annually Annually- Semi-Annually Strategic Deployment Monthly, weekly, Daily ACT Strategy Deployment L1 Action Items/Countermeasures Lean Certification- SME Kepner-Tregoe Problem Solving Standardization across plant Managing Culture Communicate Business Case- Reason for change Education/Training C H E K Fundamentals Dashboard Metrics Event Pace Lean ROI Cross Training Matrix Event Participation Cultural Development Employee Morale/Leadership Development Spheres SD Level 2 Toric SD Level 2 P L A N Semi-annually Performance Reviews KPI Board Review VSM Assessment Gemba Walks Problem Solving Results Leader Self-Assessments Value Stream Analysis Per Plan (Monthly) Lean Activities- P2B Process Kaizen Events Kaizen JDI’s Kaizen Projects Six Sigma Projects Lean Tool Belt Future State Plan Resource Planning for Action Item List 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only DO

P2B Model 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only

Questions? 6 | Global Lean Transformation Model | Christian D. Cater | 28 SEP 2016 | For Private Audience Only